BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCAR PLANER

    MDR report key: 2080210 · Received April 7, 2011

    Report

    Report Number
    1822565-2011-00871
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: AS RETURNED, THE CUTTING BLADES OF THE CALCAR PLANER ARE DULLED AND HAVE ROUNDED EDGES. THE FREQUENCY OF USE FOR THIS PLANER IS UNKNOWN. THIS COMPLAINT IS LIKELY DUE TO THE CALCAR PLANER BEING DULL. THE PACKAGE INSERT WARNS THAT CUTTING INSTRUMENTS WITH DULL OR DEFORMED EDGES SHOULD NOT BE USED BECAUSE THEY MAY NOT FUNCTION AS INTENDED. IF THE INSTRUMENT IS NOT SHARP WHEN USED, IT CAN POTENTIALLY CATCH ON ROUGH EDGES OF THE BONE RATHER THAN CUTTING THROUGH CLEANLY. WITH A POTENTIAL FIELD AGE OF (B)(4), IT IS POSSIBLE THAT THIS INSTRUMENT WAS WORN THROUGH NORMAL USE. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE DIMENSIONS OF THE INSTRUMENT ARE WITHIN SPECIFICATIONS WHERE MEASURED, AND THE HARDNESS OF THE MATERIAL IS IN SPECIFICATION AS WELL. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE PLANER ENGAGED THE SPIKE OF BONE, IT BROKE THE FRAGMENT OFF AS WELL AS SOME ADDITIONAL ADJACENT BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCAR PLANER LXH ZIMMER, INC. 60195167

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR